Z-1752-2020Class II

Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON...

Name: Z-1752-2020 Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON...
Creator: Beckman Coulter Inc.
Published: 2019-09-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-09-04 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024... on 2019-09-04. FDA classified it as Class II and gives the reason as "Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1752-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-04
Posted: 2020-04-20
Terminated: 2021-04-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
Product code: DJG Enzyme Immunoassay, Opiates
Reason for recall: Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: An Urgent Medical Device Recall Letter was sent to customers via either U.S. postal service or email beginning on 9-4-2019. The letter informs customers that studies indicate that cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP) and Opiate 2000 ng (OP2) Instructions For Use (IFU). This letter included the Instructions for Use (IFU) claims versus study results for each product. Customers were informed of which compounds (at specific concentrations or ranges) may result in false positive or false negative test results. The letter indicated that Laboratories should be aware of these findings but that retrospective review of results is not required. Customers were informed that resolution of this issue was handled by revising the Opiate 300 ng (OP) Reagent IFU and the Opiate 2000 ng (OP2) Reagent IFU to update the Cross Reactivity sections. Customers were also requested to provide a copy of the letter to any other laboratory to which they may have forwarded affected product. Customers were requested to acknowledge receipt of the recall notification letter by responding to Beckman Coulter within 10 days either electronically, if the letter was received via email, or manually by completing and return the enclosed Response Form. Customers were instructed to contact the Beckman Coulter Customer Support Center through their website at http://www.beckmancoulter.com/customersupport/support; or by phone at 1-800-854-3633 in the United States and Canada with any questions. Customers outside of the U.S. and Canada were instructed to contact their local Beckman Coulter Representative.
Quantity in commerce: 7,951 units
Distribution: Distributed throughout the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY.
Product codes and lots: Catalog Number 475024; UDI:15099590222970 ; Lot Numbers: M904130 and older including M802097, M803045, M804024, M805123, M806080, M808069, M809218, M810293, M901044, M902086, and M903175. .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1752-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1751-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-20
Z-1752-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-20

Product code DJG

K031002Class IISynchron Systems Opiate ReagentBeckman Coulter, Inc. / cleared 2003-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)